Medtronic (NYSE:MDT) announced that it received FDA approval for an early feasibility study of its Intrepid TTVR system.
Fridley, Minn.-based Medtronic’s Intrepid TTVR (transcatheter tricuspid valve replacement) system is designed for patients with severe, symptomatic tricuspid regurgitation, treating a diseased, damaged or malfunctioning valve that allows blood to flow back into the upper right chamber of the heart and cause eventual heart failure or death, according to a news release.
Intrepid TTVR is implanted using a transfemoral delivery catheter to assist physicians in delivering and placing the valve through a catheter in the femoral vein. Medtronic recently received breakthrough device designation from the FDA for the investigational device.
“We’re beginning a new journey that we believe will open the door for the potential future treatment of patients with tricuspid valve regurgitation, who constitute a significant, patient population suffering from heart valve disease today,” Montefiore Medical Center (New York) medical director of structural heart interventions & the study’s co-principal investigator Dr. Azeem Latib said in the release. “There has been much progress regarding transcatheter replacement of diseased aortic valves, but whether we can replace the tricuspid valve without open-heart surgery represents a new frontier in cardiology.”